Medical Device & IVD Kitting

Medical device kitting is the contract assembly of separate components, devices, reagents, consumables, labels and instructions into a single finished kit built to a manufacturer's released specification. It sits between component supply and distribution: assembly and packaging of a finished, labeled, lot-controlled kit, rather than the pick-and-pack of already-finished goods.

You are. DS2 assembles and packages to your released specification under a quality agreement, operating inside your quality system as a supplier subject to your audit and change-control requirements. Product ownership, device classification, premarket obligations, labeling decisions and UDI or GUDID responsibility remain with you as the legal manufacturer. That separation should be documented before the first build, and we treat it as a starting point rather than a detail.

Yes. FDA treats a convenience kit as a medical device in its own right, and under 21 CFR 807.20 an establishment that assembles, repackages or relabels a device must register with FDA and list. FDA exercises enforcement discretion on premarket notification for kits assembled from legally marketed components, but registration, listing, the prohibition on misbranding and good manufacturing practice requirements continue to apply.

Since 2 February 2026, FDA's Quality Management System Regulation at 21 CFR Part 820 incorporates ISO 13485:2016 by reference, so the US requirement and the international standard now point at the same quality system. They are aligned, not identical: FDA has said conformity with ISO 13485 alone does not fully satisfy the QMSR, because supplemental FDA requirements still apply, and a certificate from a registrar is not an FDA finding and does not exempt a facility from FDA inspection.

Generally yes. 21 CFR 801.20 requires a UDI on every device label and device package, so a finished convenience kit carries its own. Devices packaged within the immediate container of the kit are excepted under 801.30(a)(11), but that exception is conditional on the kit label bearing a valid UDI, and components that already arrive marked keep their manufacturer's identifier. GUDID submission is the labeler's obligation and stays with you; we can prepare, maintain and submit the data at your direction.

Yes, where components arrive individually pre-sterilized in their manufacturer's own validated sterile barrier packaging. In that model we do not create or seal a sterile barrier, and the assembled kit is supplied non-sterile; what we own is the integrity of each component's existing barrier through controlled receipt, storage, handling and inspection, with lot traceability back to each component manufacturer. Kits that require a sterile barrier to be formed or terminally sterilized fall under ISO 11607 and should be scoped with us directly.

The earliest-expiring component sets the expiry of the finished kit. Component lot and expiry are captured at receiving, the kit date is derived and printed from that, stock is rotated first-expired-first-out, and we hold to an agreed minimum remaining shelf life at the point of shipment.